To lead the Medical Information and Medical Operations function for Ipsen Australia and New Zealand, ensuring high-quality, compliant and locally relevant medical information services while providing operational and governance leadership for Medical Affairs programs.

This role combines approximately 0.5 FTE Medical Information responsibilities with approximately 0.5 FTE Medical Operations responsibilities. It serves as a strategic partner to the ANZ business, leveraging Medical Information insights, enquiry trends and customer questions to generate actionable insights that support launch excellence, lifecycle management, scientific strategy, customer engagement and patient outcomes.

The role acts as the operational governance lead for Medical Affairs, including oversight of Medical Information services, medical program governance, launch readiness, Medical Affairs procedural documentation and continuous process improvement. It partners closely with Medical Affairs, Pharmacovigilance, Quality, Regulatory, Commercial, Market Access, Finance, Supply Chain, Global Medical Information and Global Medical Affairs Operations to support compliant execution, inspection readiness and continuous improvement across the ANZ affiliate.

MAIN RESPONSIBILITIES

Medical Information leadership and delivery

- Function as the local Medical Information subject matter expert for Ipsen ANZ, maintaining strong knowledge of local products, therapeutic areas, processes and escalation pathways.
- Manage the Medical Information inbox and enquiry workflow, including triage, follow-up, documentation, escalation and closure in line with Ipsen procedures and required timelines.
- Oversee first-line and second-line Medical Information activities, including review of vendor-prepared responses, literature-based responses and customised letters to ensure scientific accuracy, readability, local relevance and compliance.
- Support localisation and maintenance of standard response documents, FAQs and product information resources, ensuring references are appropriate to the Australian and New Zealand context.
- Provide guidance to the Medical Information vendor on appropriate content inclusion, exclusion, bridging language, response structure and local requirements.
- Conduct quality control of Medical Information responses, including checks for grammar, formatting, accuracy, approved references and alignment with the original enquiry.
- Identify, escalate and help resolve vendor performance issues, including response quality, turnaround variability, localisation gaps and increased escalation volumes.
- Lead Medical Information launch readiness activities, ensuring Medical Information strategy, customer insights, FAQs, scientific content, systems readiness, vendor preparedness and post-launch enquiry monitoring are optimised to support successful product launches and indication expansions.
- Generate routine Medical Information reports, enquiry trend analyses and insights for Medical Affairs and brand teams.
- Analyse Medical Information enquiries, customer questions, product trends and emerging scientific themes to identify actionable insights that support Medical Affairs, Commercial, Market Access and cross-functional decision-making.




- Translate Medical Information insights into recommendations that inform launch planning, field medical activities, educational priorities, evidence generation opportunities and lifecycle management strategies.
- Serve as a strategic business partner for product launches and growth brands by ensuring Medical Information intelligence is integrated into launch readiness plans, training materials, FAQs, customer engagement strategies and post-launch monitoring activities.

PV, Quality and Medical Information governance

- Partner with Pharmacovigilance, Quality and Product Complaint teams to support receipt, reconciliation, follow-up and tracking of adverse events, product quality complaints and special situations received via Medical Information channels.
- Coordinate weekly PV-MI and QA/MI/PV reconciliation activities, including documentation of missed AE/PQC checks and confirmation of consistency with local records.
- Support out-of-hours and business continuity testing for Medical Information channels where required and ensure relevant documentation is completed and approved.
- Maintain relevant Medical Information procedures, work instructions, training records and quality documents, and contribute to process improvement initiatives.
- Support Medical Information training for new hires and refresher training as required, including use of enquiry channels and reporting obligations.

Medical Operations and medical program excellence

- Provide strategic and operational leadership for access programs and act as the affiliate point of contact for Global Medical Affairs from an access program and operations perspective.
- Lead the operational and governance aspects of key Medical Affairs projects, including medical programs, patient support-related initiatives and cross-functional implementation activities.
- Responsible for the overall compliance management of medical programs across Ipsen ANZ, ensuring robust governance, documentation, training and oversight.
- Act as subject matter expert for approval and maintenance of medical programs from a governance perspective, including internal process requirements and system-related enquiries.
- Act as the point of contact for ATOLS enquiries within the affiliate and support maintenance of required program documentation and approvals.
- Oversee and manage relevant access program and medical operations mailboxes, ensuring timely follow-up, escalation and documentation.
- Liaise with vendors on compliance, governance, service quality and operational aspects for medical programs and access programs.
- Support financial tracking, forecasting and budgeting for medical programs, access programs and medical operational vendors.
- Coordinate accurate phasing and accounting for Medical Affairs projects and support purchase order, vendor and contract-related processes where required.




- Responsible for submission of TGA 6-monthly SAS reports in consultation with Pharmacovigilance.
- Ensure critical documents for access programs and medical programs are archived in a timely manner and in line with Ipsen SOPs and regulatory requirements.
- Establish best-practice methodologies and continuous improvement approaches to support efficient, compliant and scalable Medical Affairs operations.
- Lead the lifecycle management of Medical Affairs-owned SOPs, work instructions, guidance documents and controlled records, ensuring documents remain current, compliant with global and local requirements, inspection-ready and aligned with evolving business needs.
- Coordinate cross-functional review, revision, approval, communication and implementation of Medical Affairs-owned SOPs and quality documents, ensuring appropriate stakeholder engagement and staff training.
- Identify opportunities to simplify, harmonise and continuously improve Medical Affairs processes through periodic SOP review and process optimisation initiatives.
- Provide Medical Operations input into new product or indication launch processes as required.

KNOWLEDGE & EXPERIENCE

- Experience in Medical Information, Medical Affairs, Medical Operations, Pharmacovigilance, Regulatory Affairs or a related pharmaceutical industry role, with demonstrated ability to operate in a regulated environment.
- Practical experience reviewing scientific or medical content for accuracy, clarity, local relevance and compliance.
- Experience using customer questions, enquiry trends or other medical insights to inform launch readiness, medical strategy or cross-functional business planning.
- Understanding of medical enquiry management, vendor oversight, adverse event/product complaint reporting pathways and quality documentation requirements.
- Experience coordinating cross-functional processes, tracking actions, managing documentation and supporting audit or inspection readiness.
- Experience updating or managing SOPs, work instructions or controlled quality documents in a regulated environment.
- Robust written and verbal communication skills, with the ability to translate complex technical information into clear, compliant communications.
- Strong attention to detail, prioritisation, stakeholder management and continuous improvement mindset.

Knowledge & Experience (preferred):
- Experience with Medical Information databases such as MISTRAL or equivalent systems.
- Experience with Veeva/CRM, document management systems, access program platforms, reporting tools, Microsoft Word, Excel and PowerPoint.
- Experience supporting access programs, patient support-related programs, launch readiness activities or medical program governance.
- Experience managing or overseeing third-party medical, PV, access program or patient support vendors.

Education / Certifications

- Bachelor degree or higher in Pharmacy, Life Sciences, Biomedical Science or a related healthcare/scientific discipline.
- Completion of required Ipsen compliance, PV, quality and role-specific training within required timelines.
- Medicines Australia CEP completion or willingness to complete within required timelines.

📌 Medical Information and Operations Manager (Melbourne)
🏢 Ipsen
📍 Melbourne